Accommodative Relief for Uncomfortable Non-Presbyopes

The Ohio State University

Status: Completed

Conditions: Asthenopia

Treatments: Device: Single Vision Contact Lens; Device: Multifocal Contact Lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03544216

2016H0382-60058303

Details and patient eligibility

About

This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).

Full description

The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.

Enrollment: 84 patients

Sex: All

Ages: 30 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Visual acuity of 20/25 or better in both eyes with habitual contact lenses
• -0.75 D or more myopic in both eyes
• -0.75 D or less astigmatism in both eyes
• Current single vision contact lens wearer who does not require a reading aid
• CLDEQ-8 score of 12 or more points with habitual contact lenses
• No history of ocular surgery or medication
• Reports digital device use of at least 3 hours per day
• No significant signs of dry eye (grade 1 or less ocular surface staining, Schirmer score of 7 mm or more, and tear break up time of 7 seconds or more in bother eyes)
• No significant binocular vision disorders in both eyes (eso or exophoria of 4 prism diopters or less at distance and near, near point of convergence of 6 mm or less, no history of strabismus or patching)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Single Vision First

Experimental group

Description:

Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks.Therefore, this group will receive both study interventions.

Treatment:

Device: Multifocal Contact Lens

Device: Single Vision Contact Lens

Multifocal first

Experimental group

Description:

Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks. Therefore, this group will receive both study interventions.

Treatment:

Device: Multifocal Contact Lens

Device: Single Vision Contact Lens